Qualified person (QP) is a technical term used in European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements.(EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC.
In countries that are part of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), the same role may be termed responsible person (RP) or authorized person (AP).
Famous quotes containing the words qualified and/or person:
“I used to join the murmurings about “Where are the qualified women?” As we murmured, we would all gaze about the room, up toward the chandelier, into the corner behind the potted palm, under the napkin, hoping perhaps that qualified women would pop out like leprechauns.”
—Jane O’Reilly, U.S. feminist and humorist. The Girl I Left Behind, ch. 5 (1980)
“Like children, the elders are a burden. But unlike children, they offer no hope or promise. They are a weight and an encumbrance and a mirror of our own mortality. It takes a person of great heart to see past this fact and to see the wisdom the elders have to offer, and so serve them out of gratitude for the life they have passed on to us.”
—Kent Nerburn (20th century)